The Responsible Party can be either a sponsor or a principal investigator (PI). The term "responsible party" is either of the following:
- Sponsor of the clinical trial (as defined in 21 CFR 50.3 or successor regulation)
- or - - Principal investigator of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee, so long as the principal investigator is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements for the submission of clinical trial information.
The system displays different fields depending on what you select:
- If you indicate that the Responsible Party is the Principal Investigator, this section expands to display the investigator's title and organization affiliation. The investigator's name is generated from the name you selected as Principal Investigator in the Lead Organization/Principal Investigator section.
- If you indicate that the Responsible Party is the Sponsor-Investigator, this section expands to display the investigator's name and title. The investigator's name is generated from the name you selected as Principal Investigator in the Lead Organization/Principal Investigator section. However, you can change the investigator's name in this case.
How to Abstract Sponsors and Responsible Parties
Search for the trial of interest. For instructions, refer to Searching for Trials in PA.
In the search results, click the NCI Trial Identifier link for that trial. The Trial Identification page appears.
On the Trial Identification page, check out the trial. For instructions, refer to Checking In and Checking Out Trials. (This checkout step is optional for Super Abstractors.)
- On the Administrative Data menu, click General Trial Details. The General Trials Details page appears.
On the General Trials Details page, in the Lead Organization/Principal Investigator section, make sure the specified organization and person match the lead organization and principal investigator specified in the protocol document.
- In the Sponsor/Responsible Party section, in the various fields, specify the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.
Instructions for recording Sponsors/Responsible Parties
Field Label
Description/Instructions
Sponsor
Click Look Up Sponsor and search for the organization as per the instructions in Searching for Organizations.
Responsible Party
Indicate the party who is responsible for the trial. Select one of the following options:
Sponsor - Name of primary organization that oversees implementation of study and is responsible for data analysis. For applicable clinical trials, sponsor is defined in 21 CFR 50.3. For further elaboration on the definition of Sponsor with respect to responsible party, see http://prsinfo.clinicaltrials.gov/ElaborationsOnDefinitions.pdf.
- Principal Investigator - Primary medical researcher in charge of carrying out a clinical trial's protocol.
- Sponsor-Investigator - Responsible party is both the sponsor and the investigator.
Investigator*
If the Responsible Party is the Principal Investigator, this field is pre-populated with the name you entered for the Principal Investigator in the Lead Organization/Principal Investigator section.
If the Responsible Party is the Sponsor-Investigator, this field is pre-populated with the name you entered for the Principal Investigator in the Lead Organization/Principal Investigator section. To change the investigator's name, click Look Up Sponsor, and follow the instructions in Searching for Persons.
Investigator Title*
This field is pre-populated. Enter a new title in the field provided if other than Principal Investigator.
Investigator Affiliation*
This field is pre-populated with the organization you entered as Sponsor.
If the Responsible Party is the Principal Investigator, you can change the affiliated organization. To change the investigator's affiliation, click Look Up Organization, and follow the instructions in Searching for Organizations.
- Click Save. For instructions on completing the other sections of the General Trials Details page, refer to the following pages:
